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Replimune Group (NasdaqGS:REPL) FY Conference Transcript
2026-01-14 22:32
Replimune Group (NasdaqGS:REPL) FY Conference January 14, 2026 04:30 PM ET Company ParticipantsNone - Company RepresentativeSushil Patel - CEOEmily Hill - CFOConference Call ParticipantsNone - Analyst 1Anupam Rama - Senior Biotech AnalystNone - Analyst 2Anupam RamaAll righty, let's go ahead and get started. Welcome, everyone, to the 44th Annual JPMorgan Healthcare Conference. My name is Anupam Rama. I am one of the Senior Biotech Analysts here at JPMorgan. I'm joined by my squad, Joyce Zhou, Priyanka Grover ...
Replimune Group (NasdaqGS:REPL) FY Earnings Call Presentation
2026-01-14 21:30
Click to edit Master title style January 14, 2026 JPM Healthcare Conference Igniting a systemic immune response to cancer with oncolytic immunotherapy © 2026 Replimune Group Inc. JPM 2026 Presentation 1 Click to edit Master text styles Safe harbor © 20256 Replimune Group Inc. Replimune Group Inc. 3 Click to edit Master title style RPx Oncolytic Immunotherapy Overcoming Historical Hurdles ~150 Accounts Ready on Day 1 Go-to market model optimized to enable oncologist/interventional radiologist (IR) coordinati ...
Immvira Bioscience Inc. - B(H0315) - Application Proof (1st submission)
2026-01-13 16:00
The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of Immvira Bioscience Inc. 亦諾微醫藥* (the "Company") (Incorporated in the Cayman Islands with limited liability) WARNING ...
CG Oncology (NasdaqGS:CGON) Earnings Call Presentation
2026-01-08 23:00
Attacking Bladder Cancer for a Better Tomorrow | 1 Disclaimer and Forward -Looking Statements We caution you that this presentation contains forward -looking statements about us and our industry. All statements other than s tatements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, rese arch and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned clinical ...
New Cretostimogene Grenadenorepvec Data Highlight its Potential to Become the Backbone Therapy for High-Risk Non-Muscle Invasive Bladder Cancer
Globenewswire· 2025-12-05 13:30
Core Insights - CG Oncology, Inc. announced promising topline data from BOND-003 Cohort P and CORE-008 Cohort A, indicating efficacy, safety, and tolerability of cretostimogene for bladder cancer treatment [1][2][3] BOND-003 Cohort P Results - The BOND-003 trial demonstrated High-Grade Event-Free Survival (HG-EFS) rates of 95.7% at 3 months, 84.6% at 6 months, and 80.4% at 9 months among 51 evaluable patients [4][9] - No Grade 3 or greater treatment-related adverse events (TRAEs) were reported, and no patients progressed to muscle-invasive bladder cancer (MIBC) [5][9] - The study included 56 patients across 35 clinical sites in the U.S. and Japan [6] CORE-008 Cohort A Results - CORE-008 Cohort A showed an overall Complete Response (CR) rate of 83.7% in evaluable patients, with an 88.0% CR rate for optimized administration compared to 79.2% for original administration [7][10] - The safety profile was consistent with previous trials, with no serious adverse events or treatment-related discontinuations reported [8][10] Cretostimogene Overview - Cretostimogene is an investigational oncolytic immunotherapy for Non-Muscle Invasive Bladder Cancer (NMIBC), with over 400 patients involved in its clinical development [11] - The company is conducting two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC [11] Company Background - CG Oncology focuses on developing and commercializing bladder-sparing therapies for bladder cancer patients, aiming to improve their quality of life [12]
CG Oncology to Present Results on Cretostimogene Grenadenorepvec at the Society of Urologic Oncology (SUO) 26th Annual Meeting
Globenewswire· 2025-11-25 21:05
Core Insights - CG Oncology is presenting new data on cretostimogene, an investigational therapy for non-muscle invasive bladder cancer (NMIBC), at the Society of Urologic Oncology (SUO) 26th Annual Meeting [1][2] - The presentations include topline results from BOND-003 Cohort P and CORE-008 Cohort A, reinforcing cretostimogene's potential as a backbone immunotherapy for NMIBC patients [2][5] Late-Breaking Podium Presentations - BOND-003 Cohort P focuses on high-risk, papillary-only, BCG-unresponsive NMIBC, with results presented by Dr. Mark D. Tyson on December 5, 2025 [3] - CORE-008 Cohort A evaluates high-risk BCG-naïve NMIBC, with initial results presented by Dr. Trinity J. Bivalacqua on December 5, 2025 [4] Posters - A poster on durable 24-month outcomes from BOND-003 Cohort C will be presented by Dr. Mark D. Tyson on December 3, 2025 [4] - Another poster on CORE-008 Cohort B, assessing intravesical cretostimogene in BCG-exposed NMIBC patients, will also be presented by Dr. Trinity J. Bivalacqua on December 3, 2025 [4] - A poster discussing a patient-centric expanded access program for cretostimogene will be presented by Dr. Sarah P. Psutka on December 4, 2025 [4] About Cretostimogene Grenadenorepvec - Cretostimogene is an investigational oncolytic immunotherapy delivered intravesically, with over 400 patients studied in its clinical development program [5] - The program includes two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC, along with a Phase 2 trial, CORE-008 [5] About CG Oncology - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing therapies for bladder cancer, aiming to improve the quality of life for patients [6]
CG Oncology Reports Third Quarter 2025 Financial Results and Provides Business Updates
Globenewswire· 2025-11-14 13:00
Core Insights - CG Oncology, Inc. is advancing its lead therapeutic candidate, cretostimogene, for bladder cancer, with a focus on high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [2][6][10] - The company has initiated a rolling Biologics License Application (BLA) submission to the U.S. FDA, with complete submission expected in 2026 [6][7] - Financial results for Q3 2025 show a net loss of $43.8 million, an increase from $20.4 million in Q3 2024, attributed to rising R&D and G&A expenses [12][14] Corporate Highlights - The company reported a cash position of $680.3 million as of September 30, 2025, an increase from $661.1 million as of June 30, 2025, providing sufficient funds to support operations into the first half of 2028 [5][8] - Cretostimogene has received Fast Track and Breakthrough Therapy Designations, aimed at expediting its regulatory review process [7] Anticipated Upcoming Milestones - Topline data from the BOND-003 Cohort P trial is expected in Q4 2025, focusing on HR BCG-unresponsive NMIBC without CIS [7] - Initial results from the CORE-008 Cohort A trial are also anticipated in Q4 2025, targeting HR BCG-naïve NMIBC [7] Financial Highlights - Total revenues for Q3 2025 were $1.666 million, compared to $43,000 in Q3 2024, with commercial and development revenue of $1.508 million [14] - R&D expenses increased to $27.9 million in Q3 2025 from $19.6 million in Q3 2024, primarily due to higher clinical trial costs [12][14] - G&A expenses rose to $23.3 million in Q3 2025 from $8.7 million in Q3 2024, driven by increased legal and professional fees [12][14]
Genelux Corporation Reports Third Quarter 2025 Financial Results and Provides General Business Updates
Globenewswire· 2025-11-05 21:20
Core Viewpoint - Genelux Corporation is advancing its Olvi-Vec program in multiple solid tumor indications, with significant clinical milestones expected in the coming year, particularly in ovarian and lung cancer, which represent a multi-billion-dollar market opportunity [2][3][5] Clinical Program Highlights - Olvi-Vec is being developed for platinum-resistant/refractory ovarian cancer, with intraperitoneal administration aimed at delivering high doses to patients needing effective anti-tumor options [3][5] - Two ongoing trials for lung cancer are assessing the systemic delivery of Olvi-Vec, with the goal of demonstrating its efficacy across various solid tumors and its potential to resensitize tumors to platinum-based chemotherapy [3][6] - The Phase 3 OnPrime trial for ovarian cancer is expected to provide topline data in the second half of 2026, with the Independent Data Monitoring Committee recommending the continuation of the trial without modifications [5][6] Financial Results - As of September 30, 2025, the company reported cash, cash equivalents, short-term investments, and restricted cash totaling $21.0 million, which is expected to fund operations into the third quarter of 2026 [4][7] - Research and development expenses increased to $4.7 million in Q3 2025 from $4.1 million in Q3 2024, primarily due to stock compensation and increased clinical trial costs [8] - General and administrative expenses rose to $3.5 million in Q3 2025 from $2.9 million in Q3 2024, driven by stock compensation and salary increases [9] - The net loss for Q3 2025 was $8.0 million, or $0.21 per share, compared to a net loss of $6.5 million, or $0.19 per share, in Q3 2024 [9][15]
Candel Therapeutics: Oncolytic Immunotherapy Showing Broad Efficacy In Tough Tumors
Seeking Alpha· 2025-09-05 16:47
Core Insights - The article emphasizes the importance of strong brand recognition, solid financials, and growth potential in identifying profitable investment opportunities within the consumer products sector [1]. Group 1: Investment Focus - The company specializes in the consumer products sector, aiming to identify firms that combine strong brand recognition with solid financial performance and growth potential [1]. - A keen understanding of consumer trends is highlighted as a critical factor in recognizing investment opportunities [1].
CG Oncology Reports Second Quarter 2025 Financial Results and Provides Business Updates
Globenewswire· 2025-08-08 12:00
Core Insights - CG Oncology, Inc. reported positive results from the Phase 3 BOND-003 trial, highlighting the durability and tolerability of cretostimogene for bladder cancer treatment [2][6] - The company plans to submit a Biologics License Application (BLA) for cretostimogene in Q4 2025, targeting high-risk non-muscle invasive bladder cancer (NMIBC) patients unresponsive to BCG [2][11] - A recent legal victory against ANI Pharmaceuticals allows CG Oncology to focus resources on developing cretostimogene without future royalty obligations [2][5] Financial Highlights - For Q2 2025, CG Oncology reported a net loss of $41.4 million, or $0.54 per share, compared to a net loss of $18.9 million, or $0.28 per share in Q2 2024 [11][14] - Research and development expenses increased to $31.3 million in Q2 2025 from $18.5 million in Q2 2024, primarily due to higher clinical trial costs and increased headcount [11][14] - General and administrative expenses rose to $17.4 million in Q2 2025 from $7.5 million in Q2 2024, attributed to personnel-related costs and legal expenses [11][14] Cash Position - As of June 30, 2025, CG Oncology had cash and cash equivalents of $661.1 million, down from $688.4 million as of March 31, 2025 [11][16] - The company expects its current cash position to fund operations into the first half of 2028 [11] Clinical Development Updates - The company presented best-in-disease durability data from the BOND-003 trial, showing a 75.5% complete response rate at any time and a median duration of response of 28 months [6] - The CORE-008 trial was initiated to evaluate the combination of cretostimogene and gemcitabine in high-risk BCG-exposed NMIBC patients [5][6] - Anticipated milestones include the completion of Phase 3 enrollment for PIVOT-006 in Q3 2025 and topline data from various trials expected in Q4 2025 and 1H 2026 [4][11]